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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study short report, but giving the main details of design and performance, intensified conditions with still not irritant result

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
extented exposure, add. scarified skin
GLP compliance:
no
Remarks:
pre dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
SPF-Albino-Himalayan-Kaninchen
Strain: Hoe:HIMK(SPFWiga)

- Weight at study initiation: 1,5-2 kg
- Housing: single
- Diet (e.g. ): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg/ site
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: surgical gauze + occlusive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 h

SCORING SYSTEM:
§ 1500.41 Federal Register 38, No. 187, 27. 9. 1973, p 27019

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered not irritant.
Executive summary:

The fur of 6 rabbits (weight; 1,5 to 2,0 kg) was clipped free of hair with aa electrical clipper at two adjacent sites (each 3 x 3 em)

One of the two sites was sacrified additionally.

Pieces fot surgigal gauze (2,5 x 2.5 cm²) loaded with 500 mg of the powder were fixed using adhesive tape to the application sites. Sites were covered occlusively with 6 -8 cm wide PVC foiles fixed to the trunk with an elastic bandage.

Exposure lasted for 24 hours. Immediately afterwards observations were made and repeated 48 and 72 hours after the start of exposure.

Based on the findings the irritation index was calculated according to § 1500.41 Federal Register 38, No. 187, 27. 9. 1973, p 27019, Result: Der test item was tolerates by all animals without any effect (Index = 0) and is therefore considered not irritant.